Quotas - 1999
[Federal Register: October 21, 1999 (Volume 64, Number 203)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled Substances: Proposed Aggregate Production Quotas for 2000
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed year 2000 aggregate production quotas.
SUMMARY: This notice proposes initial year 2000 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA).
DATES: Comments or objections should be received on or before November 22, 1999.
ADDRESSES: Send comments or objections to the Deputy Administrator, Drug Enforcement Administration, Washington, D.C. 20537, Attn.: DEA Federal Register Representative (CCR).
FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, D.C. 20537, Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION: Section 306 of the CSA (21 U.S.C. 826) requires that the Attorney General establish aggregate production quotas for each basic class of controlled substance listed in Schedules I and II. This responsibility has been delegated to the Administrator of the DEA by Section 0.100 of Title 28 of the Code of Federal Regulations. The Administrator, in turn, has redelegated this function to the Deputy Administrator of the DEA pursuant to Section 0.104 of Title 28 of the Code of Federal Regulations.
The proposed year 2000 aggregate production quotas represent those quantities of controlled substances that may be produced in the United States in 2000 to provide adequate supplies of each substance for: the estimated medical, scientific, research, and industrial needs of the United States; lawful export requirements; and the establishment and maintenance of reserve stocks. These quotas do not include imports of controlled substances for use in industrial processes.
In determining the proposed year 2000 aggregate production quotas, the Deputy Administrator considered the following factors: total actual 1998 and estimated 1999 and 2000 net disposals of each substance by all manufacturers; estimates of 1999 year-end inventories of each substance and of any substance manufactured from it and trends in accumulation of such inventories; product development requirements of both bulk and finished dosage from manufacturers; projected demand as indicated by procurement quota applications filed pursuant to Section 1303.12 of Title 21 of the Code of Federal Regulations; and other pertinent information.
In the past, the basic class methamphetamine has been listed as desoxyephedrine for aggregate production quota purposes. For clarification, the desoxyephedrine aggregate production quota was divided into a methamphetamine for sale quota and a levo-desoxyephedrine quote. The aggregate production quota for methamphetamine for conversion was listed separately. In order to more accurately reflect the nomenclature used in Section 1308.12(d) of Title 21 of the Code of Federal Regulations, levo-desoxyephedrine, methamphetamine (for sale) and methamphetamine (for conversion) are now listed under the basic class of methamphetamine.
Pursuant to Section 1303 of Title 21 of the Code of Federal Regulations, the Deputy Administrator of the DEA will, in early 2000, adjust aggregate production quotas and individual manufacturing quotas allocated for the year based upon 1999 year-end inventory and actual 1999 disposition data supplied by quota recipients for each basic class of Schedule I or II controlled substance.
Therefore, under the authority vested in the Attorney General by Section 306 of the CSA of 1970 (21 U.S.C. 826), delegated to the Administrator of the DEA by Section 0.100 of Title 28 of the Code of Federal Regulations, and redelegated to the Deputy Administrator pursuant to Section 0.104 of Title 28 of the Code of Federal Regulations, the Deputy Administrator hereby proposes that the year 2000 aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, by established as follows:
|Basic class||Proposed year 2000 quotas|
|Lysergic acid diethylamine (LSD)||38|
|Codeine (for sale)||54,504,000|
|Codeine (for conversion)||52,384,000|
|Hydrocodone (for sale)||20,208,000|
|Hydrocodone (for conversion)||20,700,000|
|Methadone (for sale)||8,347,000|
|Methadone (for conversion)||600,000|
|Methamphetamine - 595,000 grams of devo-desxyephedine for use in a non-controlled, non-prescription product; 750,000 grams for methamphetamine for conversion to a Schedule III product; and 74,000 grams for methamphetamine (for sale)||1,419,000|
|Morphine (for sale)||14,706,000|
|Morphine (for conversion)||97,160,000|
|Noroxymorphone (for sale)||25,000|
|Noroxymorphone (for conversion)||2,067,000|
|Oxycodone (for sale)||22,020,000|
|Oxycodone (for conversion)||271,000|
The Deputy Administrator further proposes that aggregate production quotas for all other Schedules I and II controlled substances included in Sections 1308.11 and 1308.12 of Title 21 of the Code of Federal Regulations be established at zero.
All interested persons are invited to submit their comments and objections in writing regarding this proposal. A person may object to or comment on the proposal relating to any of the above-mentioned substances without filing comments or objections regarding the others. If a person believes that one or more of these issues warrant a hearing, the individual should so state and summarize the reasons for this belief.
In the event that comments or objections to this proposal raise one or more issues which the Deputy Administrator finds warrant a hearing, the Deputy Administrator shall order a public hearing by notice in the Federal Register, summarizing the issues to be heard and setting the time for the hearing.
The Office of Management and Budget has determined that notices of aggregate production quotas are not subject to centralized review under Executive Order 12866. This action has been analyzed in accordance with the principles and criteria contained in Executive Order 12612, and it has been determined that this matter does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
The Deputy Administrator hereby certifies that this action will have no significant impact upon small entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 6501 et seq. The establishment of aggregate production quotas for Schedules I and II controlled substances is mandated by law and by international treaty obligations. Aggregate production quotas apply to approximately 200 DEA registered bulk and dosage form manufacturers of Schedules I and II controlled substances. The quotas re necessary to provide for the estimated medical, scientific, research and industrial needs of the United States, for export requirements and the establishment and maintenance of reserve stocks. While aggregate production quotas are of primary importance to large manufacturers, their impact upon small entities is neither negative nor beneficial. Accordingly, the Deputy Administrator has determined that this action does not require a regulatory flexibility analysis.
Dated: October 12, 1999.
Donnie R. Marshall,
[FR Doc. 99-27428 Filed 10-20-99; 8:45 am]
BILLING CODE 4410-09-M
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).